Application 203978
- Type
- ANDA
- Sponsor
- INFORLIFE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | No | No |
| 002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | |
| A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203978-001 | AP |
| A203978-002 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | 8072bd15b7f6… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203978-001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203978-002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2024-04-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203978-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A203978-002 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A203978-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203978-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203978-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203978-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203978-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203978-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203978-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203978-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203978-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203978-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203978-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203978-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203978-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203978-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203978-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203978-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203978-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203978-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203978-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203978-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203978-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203978-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203978-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203978-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203978-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203978-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203978-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203978-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203978-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203978-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203978-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A203978-002 | AP | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203978-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203978-002 | AP | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| nicardipine hydrochloride | NICARDIPINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 372a4381-7302-4df7-81bb-a9521907f867 | 2026-08-10 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Micro Labs Limited | 8e8611e0-7d8c-4f30-b53a-76c6588b6ef7 | 2026-08-04 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Amerisyn LLC | 575c5dab-e832-192a-e063-6294a90a34a1 | 2026-07-24 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Caplin Steriles Limited | 9383f1dc-0310-4c87-a8f0-48c09a85d89b | 2026-06-25 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine hydrochloride | NICARDIPINE HYDROCHLORIDE | Lifestar Pharma LLC | b0e2bed3-f928-43ab-a05c-275bedc9856f | 2026-04-24 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Somerset Therapeutics, LLC | f8b49f59-7a54-425d-9eca-dfa4022a08d1 | 2026-04-20 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | a3e33add-0d09-423a-9109-42e5ba7148d5 | 2026-04-13 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Cardene IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | 5499cfac-9147-4d5d-a8cb-f8d64f1481af | 2026-04-13 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e | 2026-03-27 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | cdafe6cc-b03e-4e72-9d0a-6baa977149d6 | 2026-03-06 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 3955d43d-a87f-4d2c-b90e-3ecf0d6aa148 | 2026-01-29 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Amici Pharma Inc | edda985c-004e-4487-b856-13cf2cdb900f | 2026-01-08 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | 5749599d-ff2a-42e4-aa72-cd25013feee8 | 2025-12-29 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Sagent Pharmaceuticals | c576c9d5-853b-4e93-be6c-3579dfa5564c | 2025-12-29 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | d1e275b8-c71a-4e8b-bca0-cfea048b5343 | 2025-12-22 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Chengdu Shuode Pharmaceutical Co., Ltd | 433dbca3-0a86-44c2-835d-1051c1c93878 | 2025-11-10 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Qilu Pharmaceutical Co., Ltd. | 7433b5cd-9c3a-428a-bcaf-00f02cd52633 | 2025-04-23 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Cipla USA Inc. | 570af1f8-6718-4b40-ae89-0f738d330ebd | 2025-04-08 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9d898911-d811-2a78-e053-2995a90af784 | 2025-01-08 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Archis Pharma LLC | d0070638-bea5-413a-8658-4c752c6104f5 | 2024-12-05 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78587 | ORIG | 2024-05-31 |